FDA grants Merus a breakthrough therapy designation for petosemtamab for treating certain patients with recurrent or metastatic head and neck squamous...
FDA issues a warning for healthcare providers and consumers not to use Cue Healths Covid-19 tests due to the increased risk of false results.
FDA issues Eugia Pharma Specialties (an Aurobindo subsidiary) a seven-item Form-483 following a 5/3-concluded inspection at its sterile drug manufactu...
FDA accepts for priority review a Regeneron Pharmaceuticals and Sanofi supplemental BLA for Dupixent (dupilumab) as an add-on maintenance treatment fo...
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for GlaxoSmithKlines Jemperli (dostarlimab-gxly), i...
FDA tells Moderna that it needs a couple more weeks to complete the review of its BLA for mRNA-1345, the companys investigational respiratory syncytia...
Megadyne recalls and removes from the market all Mega Soft Pediatric Patient Return Electrodes after receiving reports of patient burn injuries.
FDA gives SN Bioscience a fast-track designation for its nanoparticle anticancer drug SNB-101 for treating small cell lung cancer.
